In this webinar, you will learn how to create a summary for the Animal Studies and Human Clinical Studies sections of your 510k submission.
Why you should register for the Animal Studies & Human Clinical Studies Webinar
In this webinar, you will learn exactly how to prepare the Animal Studies and Human Clinical Studies sections of your submission. FDA guidance documents regarding both types of studies are also included.
What you will receive for $79
- a recording of the webinar you can replay anytime
- the native slide deck for this webinar
There are 22 slides in this presentation. The is 38 minutes in duration.
Q&A
Please submit questions to me by email at rob@13485cert.com regarding the Animal Studies & Human Clinical Studies Webinar. If you have company-specific questions, please send me a request to set up a private call to discuss your specific issues.
Animal Studies & Human Clinical Studies Webinar $79
In this webinar you will learn how to create a summary for the Animal Studies and Human Clinical Studies sections of your 510k submission.
Additional Resources for 510k submissions
If you would like additional training on 510k submissions or you would like to access Medical Device Academy’s templates, you can purchase all of our templates and 510k webinars on our 510k course webpage.
About Your Instructor
Rob Packard is a regulatory consultant with ~25 years of experience in the medical device, pharmaceutical, and biotechnology industries. He is a graduate of UConn in Chemical Engineering. Rob was a senior manager at several medical device companies—including the President/CEO of a laparoscopic imaging company. His Quality Management System expertise covers all aspects of developing, training, implementing, and maintaining ISO 13485 and ISO 14971 certifications. From 2009 to 2012, he was a lead auditor and instructor for one of the largest Notified Bodies. Rob’s specialty is regulatory submissions for high-risk medical devices, such as implants and drug/device combination products for CE marking applications, Canadian medical device applications, and 510(k) submissions. The most favorite part of his job is training others. He can be reached via phone at 802.281.4381 or by email. You can also follow him on Google+, LinkedIn, or Twitter.